CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 793 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00489424
NCT00489424Phase 4Completed
CompareCT.gov

A Randomized, Multicenter, Double-blind, Double-dummy, Parallel-group Study of Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an i.v. Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass

Novartis Pharmaceuticals·interventional·Posted Jun 21, 2007·Updated Feb 18, 2011

In Brief

A Phase 4 clinical trial evaluating Placebo, Acetaminophen, and 1 other intervention for Osteoporosis. Completed, enrolled 793 participants across 1 site.

Detailed Summary

This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of occurrence and the severity of post dose symptoms that may occur during the 3 day period following a zoledronic acid infusion in post menopausal women with low bone mass.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 21, 2007
Enrollment StartJun 1, 2007
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 19.0 years ago

Interventions

Placebodrug

Acetaminophendrug

Fluvastatindrug